EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05723107
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.
  • Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) — DEVICE
    EUS-RFA will be delivered using the EUSRA RF Electrode, which is a sterile, single-use electrosurgical accessory for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator (VIVA Combo RF Generator). The device will be used during a routine EUS, which is a minimally invasive procedure used to assess gastrointestinal diseases. Each EUS-RFA procedure will last approximately 60 minutes.

Study Details

This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.

Key Dates

Start date
Mar 31, 2023
Status verified
Nov 2025
Primary completion
Nov 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy plus EUS-RFA
    Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) and chemotherapy will be administered as part of standard of care treatment for PDAC in patients receiving palliative second- or third-line therapy for unresectable non-metastatic pancreatic cancer. Study participants will undergo 3 identical EUS-RFA procedures, administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11). During each EUS-RFA procedure, a tumor biopsy will also be taken for single cell RNA sequencing. Chemotherapy will be administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), Window 4 (Weeks 9-11), and Window 5 (Weeks 13-15).

Primary Outcome Measure

Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0 [ Time Frame: Up to Week 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tisch HospitalNew YorkNew York10016
Tamas A. Gonda, MD
[email protected]
212-263-3095

Find similar trials in New York, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Tisch Hospital· New York, NY

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